MONTVILLE, N.J., Oct. 29 /PRNewswire/ -- Berlex Laboratories, Inc. announced
today that the Committee for Proprietary Medicinal Products (CPMP) has issued
a positive scientific opinion for use of BETASERON(R) (Interferon beta-1b) to
treat people with Secondary Progressive multiple sclerosis (MS). The CPMP
reached this opinion at an October 22, 1998 meeting in London after careful
review of data from a European clinical study using BETASERON(R) to treat
people with this more advanced form of MS. The CPMP opinion is an important
milestone in the European regulatory review process. Berlex's parent company
expects to receive final European Commission approval in the first quarter of
1999 for the use of BETASERON(R) to treat this patient group.
Worldwide to date, no medical treatment has received marketing approval for
the Secondary Progressive form of MS. Using the European clinical study data,
Berlex Laboratories, Inc. and Chiron Corporation filed a Supplemental
Biological License Application (BLA) with the Food and Drug Administration in
June 1998 seeking a Secondary Progressive indication in the U.S. for
BETASERON(R). This application is currently under review.
BETASERON(R), which is currently indicated both in the U.S. and Europe to
treat Relapsing-Remitting forms of MS, was the only therapy that reported a
beneficial treatment effect in patients with Secondary Progressive MS. In
this clinical study, patients treated with BETASERON(R) showed a significant
delay in disease progression and in disability, a reduced frequency of MS
attacks, and a delay in time to become wheelchair dependent.
In the European Secondary Progressive MS trial, BETASERON(R) demonstrated
similar side effects as seen previously in other studies including flu-like
symptoms, dyspnea, menstrual disorders, injection site reactions, and
injection site necrosis. The analyses did not reveal increases in depression,
suicides or attempted suicides.
"The CPMP's positive opinion is exciting news both for the company and for
people with MS. These data, from the pivotal European study, have stood up
under the rigorous scientific review of the European CPMP," said Howard Robin,
Vice President and General Manager, Berlex Laboratories. "BETASERON(R) was
the innovator treatment for Relapsing-Remitting MS treatment, and we are
confident that it will soon become a treatment option for people with
Secondary Progressive MS. The European data show that MS patients can benefit
from BETASERON(R) therapy at all stages of the disease."
The European clinical study included 718 patients with Secondary Progressive
MS who completed a minimum of two years of treatment. The study was a double-
blind, randomized, placebo-controlled trial, conducted in twelve European
countries. All study participants on active drug received 8 million
International Units (MIUs) of BETASERON(R) subcutaneously every-other-day.
This is the same treatment schedule used for patients with Relapsing-Remitting
MS.
Committed to developing novel therapeutics that address unmet medical needs,
Berlex Laboratories, Inc. researches, manufactures, and markets ethical
pharmaceuticals in three strategic areas: Diagnostic Imaging, Female
Healthcare, and Therapeutics for life-threatening and disabling diseases.
Berlex business divisions are located in Montville and Wayne, New Jersey and
in Richmond, California.
SOURCE Berlex Laboratories, Inc.
CO: Berlex Laboratories, Inc.
ST: New Jersey
IN: MTC HEA
SU: